A Phase 1/2 interventional study of JAB-30355 and JAB-30355 in Solid Tumors, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
Exclusion Criteria:
Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)
Drug: JAB-30355
Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
Drug: JAB-30355
Oral administration
Oral administration
Dose limiting toxicity (DLT)
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Time frame: Approximately one year
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
Time frame: Approximately three years
Peak Plasma Concentration (Cmax)
Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Time frame: Approximately three years
Time to reach the observed maximum (peak) concentration (Tmax)
Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Time frame: Approximately three years
Terminal half-life (t1/2)
Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Time frame: Approximately three years
Objective response rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Approximately three years
Duration of response (DOR)
DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.
Time frame: Approximately three years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jacobio Pharmaceuticals Co., Ltd.